Building Evidence for Additive Manufacturing: What Questions Remain?

For decades, orthopaedic device manufacturers, suppliers, service providers and surgeons have explored the adoption of additive manufacturing. Many of those entrenched in its actual use believe that the hype surrounding the technology has climaxed, and rightfully so. We’ve reached a seemingly universal expectation that additive manufacturing will enhance medicine. But in order for additive to move from tinkering technology to widely-used process, it’s imperative to prove its long-term benefits. To date, there is a lack of clinical and economic data and reimbursement rates for many uses of additive manufacturing.

In recent months, the additive manufacturing hype has been debated by our own editorial team. We’ve questioned why many of our interviews have unintentionally turned to the use of additive manufacturing, revealing great interest in and benefits of the technology, and the many unknowns—cost, design, production—that have held up companies from fully committing to its adoption. We’ve asked ourselves what it will take to make additive manufacturing a commonly used process and wondered, who will lead the charge?

This workshop focused on three uses of additive manufacturing in medicine: anatomical models, patient-specific instruments and custom implants, and convened researchers, surgeons, radiologists, device companies, healthcare economists and additive manufacturing suppliers. Clinical, engineering and economic perspectives were presented for each of the three uses, and then attendees were divided by medical segment, such as orthopaedics or cardiac, to work through the challenging questions of building evidence.

Fundamental questions to answer included: What are the technology’s benefits for each stakeholder? When is additive manufacturing a better alternative to current processes? How can we ensure that payors will cover the technology? What improvements need to be made, e.g. to materials and printing, to make additive manufacturing more effective?

When the breakout discussions began, I sat with representatives from DePuy Synthes, Smith & Nephew, Stryker, Wright Medical, Zimmer Biomet and others. Each individual assumed a different role, be that engineer, surgeon, hospital, patient or payor, and we debated from our assigned perspective (sometimes intensely) on ways to pursue evidence creation. The group discussed the accuracy of current diagnostic tools, expected outcomes, appropriate assessment models and study designs.

All of the discussions heavily weighted payor and hospital expectations, meaning operating room efficiency and complication rates—both linked to cost—over functional score and surgical accuracy outcomes, a sign of trends in today’s healthcare environment. As more hospitals build additive manufacturing labs and as more OEMs roll out patient-specific cutting guides, surgeons are experiencing the benefits. It’s clear to me that industry believes surgeons and patients are not the audience that needs convincing of the technology’s future. Evidence needs to be built for hospitals and payors—today’s primary decision makers.

The SME group’s desire is to publish guidelines for industry to adopt and surgeon societies to back—the latter representing an important link for reimbursement approval. We’ll provide updates in the coming months on the guidelines and practices to consider when building clinical and economic evidence for your additive manufacturing programs. Whether you’ve dedicated your career to marrying additive manufacturing and orthopaedics or you’re in the early stages of exploring its possibilities, it’s in everyone’s best interest to ensure that expectations aren’t inflated and that the best technology is deployed for the best patient outcome.

As voiced by Wilfried Vancraen, CEO of Materialise, the founding partner and sponsor of the building evidence event, “The fact is, we can only be successful if we take an evidence-based approach across the industry, acting in concert with a set of protocols, methodologies and measurement guidelines. With the proper scientific rigor, our ambition of gaining widespread acceptance of medical 3D printing will be realized more swiftly, and the patients whom we aim to serve will benefit the most.”

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